Exforge (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 0078-0488-15

EXFORGE®
(amlodipine and valsartan)Tablets

5 mg*/160 mg

*each tablet contains 6.9 mg of amlodipine besylate

30 tablets

Rx only

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0488-15
							EXFORGE®
							(amlodipine and valsartan)
							Tablets
							5 mg*/160 mg
							*each tablet contains 6.9 mg of amlodipine besylate
							30 tablets
							Rx only
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0489-15

EXFORGE®
(amlodipine and valsartan)Tablets

10 mg*/160 mg

*each tablet contains 13.9 mg of amlodipine besylate

30 tablets

Rx only

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0489-15
							EXFORGE®
							(amlodipine and valsartan)
							Tablets
							10 mg*/160 mg
							*each tablet contains 13.9 mg of amlodipine besylate
							30 tablets
							Rx only
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0490-15

EXFORGE®
(amlodipine and valsartan)Tablets

5 mg*/320 mg

*each tablet contains 6.9 mg of amlodipine besylate

30 tablets

Rx only

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0490-15
							EXFORGE®
							(amlodipine and valsartan)
							Tablets
							5 mg*/320 mg
							*each tablet contains 6.9 mg of amlodipine besylate
							30 tablets
							Rx only
							NOVARTIS
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0078-0491-15

EXFORGE®
(amlodipine and valsartan)Tablets

10 mg*/320 mg

*each tablet contains 13.9 mg of amlodipine besylate

30 tablets

Rx only

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0491-15
							EXFORGE®
							(amlodipine and valsartan)
							Tablets
							10 mg*/320 mg
							*each tablet contains 13.9 mg of amlodipine besylate
							30 tablets
							Rx only
							NOVARTIS
(click image for full-size original)

EXFORGE amlodipine besylate and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0488
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
VALSARTAN (VALSARTAN) VALSARTAN 160 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (dark yellow) Score no score
Shape OVAL (ovaloid shaped) Size 14mm
Flavor Imprint Code NVR;ECE
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0488-15 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021990 06/20/2007
EXFORGE amlodipine besylate and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0489
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
VALSARTAN (VALSARTAN) VALSARTAN 160 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape OVAL (ovaloid shaped) Size 14mm
Flavor Imprint Code NVR;UIC
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0489-15 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021990 06/20/2007
EXFORGE amlodipine besylate and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0490
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
VALSARTAN (VALSARTAN) VALSARTAN 320 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (very dark yellow) Score no score
Shape OVAL (ovaloid shaped) Size 19mm
Flavor Imprint Code NVR;CSF
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0490-15 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021990 06/20/2007
EXFORGE amlodipine besylate and valsartan tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0491
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
VALSARTAN (VALSARTAN) VALSARTAN 320 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
HYPROMELLOSES
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (dark yellow) Score no score
Shape OVAL (ovaloid shaped) Size 19mm
Flavor Imprint Code NVR;LUF
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0491-15 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021990 06/20/2007
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 04/2021 Novartis Pharmaceuticals Corporation

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